The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly

Brief summary public domain (ClinicalTrials.gov)

The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. Only patients with type 2 diabetes are meant to be included. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

Detailed description public domain (ClinicalTrials.gov)

The prognosis of pancreatic cancer is extremely unpleasant, which can be characterized with a 5-year survival rate of only about 6%. The disease usually pertaining no symptoms at the early phase, this might be one of the causes why it is discovered at a relatively late, inoperable stage - in most of the cases. The success of reducing the high mortality rate of pancreatic cancer could depend on the significant development of early diagnosis and also prevention programs. As the lifetime prevalence of pancreatic cancer is only 1.39%, screening through the whole population would be extremely expensive and difficult to manage. It would be recommended for all the individuals at high risk for pancreatic cancer to be examined. Patients newly diagnosed with diabetes have an approximately 8-fold risk for developing this type of cancer, compared to the average population. In addition to this age is also known as an independent risk factor for the pancreatic cancer. Recently there has been a biomarker panel identified, which may distinguish between pancreatic cancer and chronic pancreatitis in patients, with high sensitivity and specificity. The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes mellitus using a specific biomarker panel. Only patients with type 2 diabetes are meant to be included. Diabetes is classified by determining C-peptide levels, representing the endogenous insulin synthesis, also detecting glutamic acid decarboxylase (GADA) antibodies, the autoantibody against the pancreatic islet cells. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

Arm public domain (ClinicalTrials.gov)

elderly patients with newly diagnosed diabetes (): 1. Group with exposure: patients over 60 years of age with diabetes diagnosed within six months (newly diagnosed) 2. Control Group: without exposure; patients over 60 years, without diabetes.

Primary outcome public domain (ClinicalTrials.gov)

incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes. This will be evaluated using yes/no questions on carcinoma ductale, then the data will be summarized in order to determine the incidence. Time frame: 36 months.

Secondary outcome public domain (ClinicalTrials.gov)

mortality of pancreatic ductal adenocarcinoma in new-onset diabetic patients. Time frame: 36 months.

Secondary outcome public domain (ClinicalTrials.gov)

the proportion of localised and resectable pancreatic ductal adenocarcinoma. Time frame: 36 months.

Secondary outcome public domain (ClinicalTrials.gov)

change in body weight. Time frame: 36 months.

Secondary outcome public domain (ClinicalTrials.gov)

Change in fasting blood glucose and HbA1c. Time frame: 36 months.

Secondary outcome public domain (ClinicalTrials.gov)

Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma. Time frame: 36 months.

Secondary outcome public domain (ClinicalTrials.gov)

presence of concomitant diseases. Time frame: 36 months.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * patients over 60 years of age * diabetes diagnosed within six months (newly diagnosed) * signed written informed consent Exclusion Criteria: * continous alcohol abuse * chronic pancreatitis * previous pancreas operation/pancreatectomy * pregnancy * present malignant disease

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 2522 participants (estimated).